Mechanical VentilationNCT07467551
Turkish Validity and Reliability of the Behavioral Indicators of Pain Scale(ESCID)
A study testing The ESCID scale in people with Mechanical Ventilation and Pain Perception, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
A significant proportion of patients hospitalized in intensive care units (ICUs) require mechanical ventilation, and the treatments applied during this process may cause pain. Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mechanical Ventilation, Pain Perception, Intensive Care (ICU)
- What is being tested?
- The ESCID scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years and older
- Patients who are intubated, receiving mechanical ventilation, and unable to establish verbal communication (Glasgow Coma Scale score <14)
- Patients who have been hospitalized in the intensive care unit for at least 24 hours
Who cannot join
- Presence of postoperative complications
- Hemodynamic instability
- History of diagnosed cognitive or psychiatric disorders
- History of epilepsy or use of neuromuscular blocking agents
- History of spinal cord injury affecting motor function of all four extremities
- Individuals with a Richmond Agitation-Sedation Scale (RASS) score of -5 (unresponsive)
- Cases with suspected brain death
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: Reliability and Validity of the Turkish Version of the Behavioral Indicators of Pain Scale in Mechanically Ventilated Intensive Care Unit Patients
A significant proportion of patients hospitalized in intensive care units (ICUs) require mechanical ventilation, and the treatments applied during this process may cause pain. Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Although it is associated with delirium and agitation, pain is often an overlooked symptom in ICU patients, and a large proportion of mechanically ventilated patients continue to experience moderate to severe pain. The most common type of pain in critically ill patients is nociceptive pain, which may result from invasive procedures such as tracheal intubation, catheter insertion, aspiration, wound care, and patient repositioning. Additionally, the noisy and unfamiliar ICU environment and patients' inability to express themselves may further increase the perception of pain.
Regular assessment of pain is associated with many positive outcomes, including more effective pain management, appropriate use of analgesic and sedative medications, and shorter duration of mechanical ventilation and ICU stay. Although self-reporting of pain is considered the gold standard, many patients receiving mechanical ventilation are unable to communicate their pain. Therefore, various behavioral pain assessment scales are used to evaluate pain in ICU patients. One of these tools is the Behavioral Indicators of Pain Scale (Escala de Conductas Indicadoras de Dolor - ESCID), which was developed to assess pain in critically ill adult patients receiving mechanical ventilation who are unable to communicate. However, a Turkish version of this scale has not yet been developed. Therefore, the aim of this study is to translate the ESCID scale into Turkish, perform its cultural adaptation, and test the validity and reliability of the Turkish version.
- Being tested
- The ESCID scale
- Keywords
- mechanical ventilation, intensive care, intubation, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ESCID scaleOther
ESCID scale will be applied to 50 intubated ICU patients to assess pain through behavioral indicators.
The study evaluate the Turkish validity and reliability of the ESCID scale.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Other | The ESCID scale will be applied to a sample of 50 patients. Receives: Other: The ESCID scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Behavioral Indicators of Pain Scale (ESCID)
ESCID evaluates pain based on observable behavioral indicators, including facial expression, calmness, muscle tone, comfort level, and adaptation to mechanical ventilation. Each item is scored from 0 to 2, and the total score reflects the patient's level of pain. The application of ESCID allows systematic and objective pain assessment in patients who cannot self-report their pain.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Fenerbahce University, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Responsible party
- Principal investigator, Mehmet Burak Uyaroğlu, Fenerbahce University
- Investigators
- Mehmet Burak Uyaroğlu, Asst Prof, Principal investigator, Fenerbahce UniversityEsra Pehlivan, Prof Dr, Study director, Saglik Bilimleri UniversityHasan Kocoglu, Prof Dr, Study chair, Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467551
- Sponsor's protocol ID
- fenerbahce
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Behavioral Indicators of Pain Scale in Mechanically Ventilated Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07467551
- Acronym / sponsor ID
- fenerbahce
- Keywords
- mechanical ventilation, intensive care, intubation, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Fenerbahce University, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A significant proportion of patients hospitalized in intensive care units (ICUs) require mechanical ventilation, and the treatments applied during this process may cause pain. Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Although it is associated with delirium and agitation, pain is often an overlooked symptom in ICU patients, and a large proportion of mechanically ventilated patients continue to experience moderate to severe pain. The most common type of pain in critically ill patients is nociceptive pain, which may result from invasive procedures such as tracheal intubation, catheter insertion, aspiration, wound care, and patient repositioning. Additionally, the noisy and unfamiliar ICU environment and patients' inability to express themselves may further increase the perception of pain.
Regular assessment of pain is associated with many positive outcomes, including more effective pain management, appropriate use of analgesic and sedative medications, and shorter duration of mechanical ventilation and ICU stay. Although self-reporting of pain is considered the gold standard, many patients receiving mechanical ventilation are unable to communicate their pain. Therefore, various behavioral pain assessment scales are used to evaluate pain in ICU patients. One of these tools is the Behavioral Indicators of Pain Scale (Escala de Conductas Indicadoras de Dolor - ESCID), which was developed to assess pain in critically ill adult patients receiving mechanical ventilation who are unable to communicate. However, a Turkish version of this scale has not yet been developed. Therefore, the aim of this study is to translate the ESCID scale into Turkish, perform its cultural adaptation, and test the validity and reliability of the Turkish version.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Other | Other: The ESCID scaleThe ESCID scale will be applied to a sample of 50 patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 years and older
- Patients who are intubated, receiving mechanical ventilation, and unable to establish verbal communication (Glasgow Coma Scale score <14)
- Patients who have been hospitalized in the intensive care unit for at least 24 hours
Key exclusion criteria (7 listed)
- Presence of postoperative complications
- Hemodynamic instability
- History of diagnosed cognitive or psychiatric disorders
- History of epilepsy or use of neuromuscular blocking agents
- History of spinal cord injury affecting motor function of all four extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ESCID scaleESCID scale will be applied to 50 intubated ICU patients to assess pain through behavioral indicators. The study evaluate the Turkish validity and reliability of the ESCID scale. | Other | Single Group |
Primary outcome
The Behavioral Indicators of Pain Scale (ESCID)
Time frame: 5 month
ESCID evaluates pain based on observable behavioral indicators, including facial expression, calmness, muscle tone, comfort level, and adaptation to mechanical ventilation. Each item is scored from 0 to 2, and the total score reflects the patient's level of pain. The application of ESCID allows systematic and objective pain assessment in patients who cannot self-report their pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Burak Uyaroğlu, Asst Prof principal investigator
Fenerbahce University
Esra Pehlivan, Prof Dr study director
Saglik Bilimleri University
Hasan Kocoglu, Prof Dr study chair
Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ESCID scale in people with Mechanical Ventilation and Pain Perception, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Behavioral Indicators of Pain Scale (ESCID) (time frame: 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.